New General USP Chapter <1210> on Statistical Tools for Procedure Validation

In the Pharmacopoeial Forum 40(5) the In Process Revision of USP General Chapter <1210> - Statistical Tools for Procedure Validation has been announced.

This new chapter is seen as a complement to the chapter <1225> - Pharmacopoeial methods validation. The statistical procedures which are presented in <1210> are not only applicable for Pharmacopoeial procedures but for a variety of analytical methods, both for chemical def. APIs as well as for large biological molecules.

This comprehensive chapter introduces statistical methods that can be used during the validation of analytical methods. An analytical procedure is considered validated if it is shown that the performance characteristics are within required limits with stated confidence.

Specifically, this chapter covers the following analytical performance characteristics from a statistical point of view: